When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal
- to improve the world's health.
From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special
- a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.
We take our work personally, we do it with empathy and we're committed to making a difference.
Sr.
Associate, Regulatory Strategy (Infectious Diseases and Biological Products)Work location and arrangement: Mexico City
- HybridWe are seeking a Sr.
Associate, Regulatory Strategy with strong experience in regulatory affairs, dossier management, registration applications, and interactions with LATAM Health Authorities.
In this role, you will provide comprehensive regulatory support to the Director, Regulatory Affairs & Quality Assurance, with a focus on COFEPRIS interactions and product lifecycle management.

About the Role
This position offers the opportunity to drive regulatory strategy and execution for product programs in the LATAM region.
You will work independently on assigned deliverables while collaborating closely with global and regional partners to ensure timely, compliant submissions and approvals.

Key Responsibilities
Regulatory Strategy & PlanningSupport the Director, Regulatory Affairs & Quality Assurance in the execution of regulatory strategies and priorities for product lifecyclePerform initial regulatory impact assessments for proposed global changes and provide recommendations on submission requirements, sequencing, dependencies, documentation needs, and anticipated timelinesIdentify and assess regulatory risks,



issues, dependencies, and potential delays for assigned activities, and escalat...
Monitor regulatory requirements, COFEPRIS criteria, procedural updates, and emerging practices; provide concise regulatory intelligence and impact assessmentsSubmissions & Authority ManagementDemonstrate hands-on experience supporting regulatory procedures before COFEPRIS, including preparation and follow-up submissions, responses to queries, commitments, and post-approval activitiesCoordinate labeling and artwork regulatory activities, including review of local prescribing information and packaging components, alignment with approved conditions, and implementation of safety-related updatesMaintain an integrated regulatory portfolio view, including registrations, submissions, approvals, commitments, renewals, post-approval changes, authority requests, key dependencies, and upcoming milestonesMaintain accurate regulatory plans, submission schedules, trackers, and status reports; provide clear operational updates to the Director and relevant stakeholdersOwn assigned regulatory activities end-to-end, proactively driving inputs, timelines, document readiness, follow-up, and closureCMC & Post-Approval ChangesCoordinate regulatory assessments and execution of CMC and manufacturing-related changes, including manufacturing sites, specifications, processes, analytical methods, packaging,



and other post-approval changesCollaborate closely with Global Regulatory CMC, Quality, and Supply Chain teams to ensure alignment and timely executionDocumentation & ComplianceEnsure regulatory records, submissions, approvals, correspondence, and commitments are appropriately documented and maintained in applicable Moderna regulatory systems and repositoriesSupport the Director in the execution and follow-up of local Quality activities, priorities, and compliance requirementsSupport the management, documentation, and follow-up of quality events, including deviations, CAPAs, change controls, complaints, and other quality-related actionsSupport inspection and audit readiness activities, including preparation and organization of documentation, tracking of requests and observations, and follow-up of agreed actionsCross-Functional CollaborationCoordinate with Integral Regulatory, Regional Regulatory, Medical, Pharmacovigilance, Supply Chain, Quality, Commercial, and other cross-functional partners to obtain inputs and maintain delivery timelinesEscalate strategic decisions, material risks, and authority-sensitive matters to the Director as appropriateRequired QualificationsBA/BS degree in a scientific, engineering, or healthcare discipline5+ years of experience in the pharmaceutical industry, preferably in LATAM countries3+ years of experience in regulatory strategy or relevant training/experienceExceptional written and oral communication in English and SpanishStrong knowledge of current US and EU regulationsStrong experience with CTD format and content of regulatory filingsKnowledge and broad experience with regulatory procedures and legislation for drug development, product registration, line extensi#J-*-Ljbffr

📌 Sr. Associate, Regulatory Strategy (Xico)
🏢 Parexel
📍 Xico